BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HAKKO CO., LTD.

    Reg #: 9611481 · FEI: 3002807220 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    HAKKO CO., LTD.
    Registration Number
    9611481
    FEI Number
    3002807220
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1490 O-aza Isobe
    City
    CHIKUMA-SHI Nagano
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K961151

    Owner / Operator

    Firm Name
    HAKKO CO., LTD.
    Operator Number
    8030409
    Address
    1490 O-Aza Isobe
    City
    Chikuma-shi
    State
    Nagano
    Postal Code
    3890806
    Country
    JP

    US Agent

    Business Name
    Derek Wessman/Mr.
    Contact Name
    Derek Wessman
    Address
    3300 N Triumph Blvd Ste 100
    City
    Lehi
    State
    UT
    ZIP
    84043
    Country
    US
    Email
    [email protected]
    Phone
    801 6569278

    Products

    Device Name Product Code
    Stimulator, Nerve, Battery-Powered BXN
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Biopsy Needle FCG
    Ring (Wound Protector), Drape Retention, Internal KGW
    Instrument, Biopsy KNW

    Proprietary Names

    Stimuplex (DIG,RC, A) Hakko Spinal Needle Echostim Facet Tip Sonopsy Needle Tuohy Epidural Needle Soft Tissue Retractor Biosuc Fine Aspiration

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device